薬食監麻発1218第4号
Contents
1. 22. I VD 1 2 F 27 3
3. HH T RY Wr fY Re 3 4 TIQ 5 0Q 8
4. 11 24 1 1 QMS 2 QMS
5. 3 35 145 80 2
6. Nl
7. lt 4 8 1 2 9 1
8. 3 1 2 3 SAL Sterility Assurance Leve1 1 10 4 10
9. 6 PQ 1Q 0Q PQ 8 PQ 7 IQ 09 PQ D 10 8
10. 9 0 11 2 13
11. 2 I S 3 1 JIS T 0801 1 2010 ISO 11135 1 2007 1 2 JIS T 0806 1 2010 ISO 11137 1 2006 1 JIS T 0806 2 2014 ISO 11137 2 2013 TS0 TS 13004 2013 2 3 2 JIS T 0816 1 2010 ISO 17665 1 2006 1
12. 9 80 2 5 9 12 E Ht UI 3 r 3
13. 2 3 4 5
14. 14 9 15 16 2
15. 5 1Q Installation Qualification 6 0Q Operational Qua1ification 7 PQ Performance Qua1ification 8
16. 1218 4 26 12 18 16 169 QM S 45 46 17 3 30 0330001 GMP QMS 4 4 QMS
17. 9 11 8 1 eS 2 3 12 1
18. A a 5 1 Ss 5 1 2 3 4 s 6 1 2 7 1 fY y 3
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